BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    MODIFICA- OF EMIT CAD LIDOCAINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CLARISO PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 27, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·November 14, 2012

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 10, 2015

    2.4MM CORTEX SCREW SELF-TAPPING/12MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·October 7, 2015

    2.4MM CORTEX SCREW SELF-TAPPING/12MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·October 26, 2015

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014